Clinical trial transparency is an integral component of ethical research conduct and encompasses the dissemination of comprehensive trial details and results to a diverse array of stakeholders, including the public, patients, healthcare professionals, and researchers. It serves multifaceted purposes, fostering trust in the scientific process, facilitating informed decision-making among patients and clinicians, and averting redundancy in research efforts.
At the core of clinical trial transparency lies the concept of lay summaries, succinct documents meticulously crafted in plain language to elucidate trial results for non-experts. These summaries, pivotal for enhancing accessibility and comprehension, cater to a broad audience, including clinical trial participants, patient advocacy groups, and the general populace with varying levels of scientific literacy.
From the EU’s perspective
The European Union's robust Regulatory framework mandates the creation and dissemination of lay summaries for clinical trials conducted within its jurisdiction. Under Regulation (EU) No 536/2014, sponsors are obligated to provide clear and understandable summaries of trial results to the EU Clinical Trials Information System (CTIS)
Key principles governing lay summary creation
- Promoting health literacy, ensuring numeracy
- Employing effective visualization techniques
- Safeguarding participant privacy and confidentiality
- Avoiding promotional content, and prioritizing diverse audiences' accessibility
Stakeholders
The collaborative development of lay summaries entails engagement with a wide spectrum of stakeholders that includes:
- Patients
- Caregivers
- Patient advocacy groups
- Healthcare professionals
- Academia
- Pharmaceutical companies
- Regulatory agencies.
This inclusive approach ensures that lay summaries are tailored to meet the needs and comprehension levels of diverse audiences, thereby enhancing engagement and understanding. Moreover, sponsors may opt to provide trial results directly to investigators or third-party intermediaries for dissemination, accompanied by due recognition of their indispensable role in the research process.
In essence, lay summaries are invaluable tools for promoting clinical trial transparency, bridging the gap between scientific research and the wider community, and empowering patients and stakeholders with accessible, comprehensible information. By democratizing access to clinical trial results and fostering meaningful engagement, lay summaries contribute to a more informed, empowered, and participatory approach to clinical research and healthcare decision-making.
